Novasep, a provider of purification-based manufacturing solutions for life science molecules, has invested almost $39 million to build the world's largest chromatography plant used for the production of a large volume commercial active pharmaceutical ingredient (API).
The plant will be built on Novasep's existing Mourenx site in France and will be operational and validated within 18 months. Both the development of an advanced purification process and the plant expansion within the challenging timescale are results of the sharp increase in the projected demand for a large volume, highly purified API.
The investment follows two other significant global investments in 2012. The first is the opening of a new 2,000 mete squared facility in Shanghai and the second is a $3.8 million investment to expand the Highly Potent API (HPAPI) manufacturing capabilities at the facility in Le Mans, France.
Novasep has pioneered continuous chromatography for pharmaceutical manufacturing for more than 20 years. Its SMB and Varicol continuous chromatography technologies are currently used for commercial scale production of several chiral APIs. The new plant, designed by a Novasep in-house engineering team, will include Varicol systems with 1,200 mm diameter columns operated at up to 70 bars, the largest ever built in the pharmaceutical industry. The plant will enable the production of a highly purified API from a complex mixture. The systems will also integrate sophisticated solvent recovery systems for the recycling of 99.9% of solvents, resulting in both a very cost-effective and environmentally friendly process.
"Demand for Novasep's advanced, purification-based manufacturing capabilities in the life science industries continues to increase as drugs in development and reaching the market become more complex and specific. This necessitates our third, and largest global plant expansion in 2012," said Patrick Glaser, president and CEO of Novasep. "This successful project, the world's largest chromatography plant in the pharmaceutical industry, demonstrates the validity of the Novasep strategy which is based on the combination of synthesis, biosynthesis and purification. We thank our institutional partners for their active support and our shareholders for their strong involvement to enable this transforming project."
Beyond Novasep’s commitment, the investment has been made possible through financial and logistic support by the following partners: the association of local authorities of Lacq, the General Council of Pyrénées Atlantiques, the Regional Council of Aquitaine, the Economic Development Bureau, DIRECCTE Aquitaine, the Prefecture of Pyrénées Atlantiques, the Total Group, and OSEO, France's innovation partner. The plant will leverage the SOBEGI platform's utility supply.